Evaluation of the efficacy of probiotic supplements on illness and immunity in healthy active individuals

Not Applicable

Completed

• Conditions: pper respiratory tract illness; gastrointestinal symptoms; Infection - Other infectious diseases; colonization of antibiotic-resistant Escherichia coli; Upper respiratory tract illness

• Registration Number: ACTRN12611000130965
• Lead Sponsor: Danisco Finland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-02-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

Inclusion to the study will be determined according to physical activity levels with subjects required to be undertaking 3 exercise sessions weekly and a questionnaire to determine subject’s health in the previous month

Exclusion Criteria

All participants will be required to declare their use of dietary and/or ergogenic aids that may influence underlying immune function and/or exercise performance. All participants on immuno-modulatory medications will be excluded, including those on steroid based anti-asthma treatments. Subjects who have been on antibiotic treatments in the previous month will also be excluded. A daily illness log will be used to monitor training, health status, diet, use of supplements and other therapeutic agents. Subjects with any symptoms of gastrointestinal disease, such as Crohn’s disease, coelic disease and so on will also be excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Outcome: incidence, severity and duration of upper respiratory tract and gastrointestinal (GI) illness. Both outcomes will be measured by the use of online daily self reported illness logs. Participants will indicate the type and intensity of symptoms they experience on the log. Logs are checked weekly by the research team and participants contacted to confirm any anomalies.<br><br>The data will be analysed using SASS[Timepoint: daily during the intervention period]

Secondary Outcome Measures

Name	Time	Method
Secondary Outcome 1: Faecal microbiology[Timepoint: Pre and post supplementation];Secondary Outcome 2: Immune function will be analysed by examining peripheral blood mononuclear cell phagocytosis and natural killer cell activity. Data will be analysed with SASS[Pre and post intervention];Secondary Outcome 3: Colonization of antibiotic resistant Escherichia coli (E. coli). Samples will be cultured with antibiotic broths and incubated on agar plates. Data will be analysed by SASS.[Pre and post intervention];Secondary Outcome 4: Resilience. Participants will complete the Connor-Davidson Resilience and the data will be analysed in SASS.[questionnaire pre and post intervention];Secondary Outcome 5: Use of medications.[Daily self-report daily during the intervention period]